SHARK 46782435Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207049051), received between Oct 23, 2020 and May 23, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2023Fire; Fire

  ON APRIL 24, 2023, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDWATCH REPORT # (B)(4) REGARDING A WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, "WHILE USING THE RESECTOSCOPE. APPARENT THERE WAS A FIRE ON THE HAND PIECE TO THE RESECTOSCOPE DURING A PROSTATE PROCEDURE. NO HARM TO THE PATIENT OR SURGEON DURING THE EVENT. THE WORKING ELEMENT CAUGHT ON FIRE DURING USE." IT IS SUSPECTED THAT THE CUTTING ELECTRODE MONO 24FR 12/30°, PART ID: 46782435, BATCH # 21003532, WITHIN THE HAND PIECE (WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN) IS WHAT HAD IGNITED. THE REPORTED ISSUE CAUSED A 15 MINUTE DELAY IN THE PROCEDURE WHILE THE FIRE WAS PUT OUT AND THE BACK-UP DEVICE RETRIEVED TO COMPLETE THE SCHEDULED PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989269 ↗
• MalfunctionMay 23, 2023Fire; Fire

  ON APRIL 24, 2023, RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) RECEIVED A MEDWATCH REPORT # (B)(4) REGARDING A WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, "WHILE USING THE RESECTOSCOPE. APPARENT THERE WAS A FIRE ON THE HAND PIECE TO THE RESECTOSCOPE DURING A PROSTATE PROCEDURE. NO HARM TO THE PATIENT OR SURGEON DURING THE EVENT. THE WORKING ELEMENT CAUGHT ON FIRE DURING USE." IT IS SUSPECTED THAT THE CUTTING ELECTRODE MONO 24FR 12/30°, PART ID: 46782435, BATCH # 21003532, WITHIN THE HAND PIECE (WORKING ELEMENT PASSIVE MONO 12/30° PART 8674225, BATCH # UNKNOWN) IS WHAT HAD IGNITED. THE REPORTED ISSUE CAUSED A 15 MINUTE DELAY IN THE PROCEDURE WHILE THE FIRE WAS PUT OUT AND THE BACK-UP DEVICE RETRIEVED TO COMPLETE THE SCHEDULED PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989026 ↗
• MalfunctionOct 23, 2020Break; Break

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. THE DEVICE WAS RECEIVED VISUALLY EVALUATED. THE REPORTED CONDITION (LOOPS BURNED) WAS CONFIRMED. ACCORDING TO THE MANUFACTURER: "AFTER CONSULTATION WITH THE USER IT WAS DETERMINED THAT THE ELECTRODES WERE USED WITH A MEDTRONIC GENERATOR. THIS CAUSED THE USER TO USE 3-4 ELECTRODES PER TURP. THE GENERATOR WAS REPLACED AND IT WAS DETERMINED THAT THE MEDTRONIC GENERATOR WAS CAUSING THE LOOPS TO BURN OUT COMPLETELY. ACCORDING TO THE SUPPLEMENT BB-D366, SYSTEM OVERVIEW "SHARK" RESECTOSCOPES, THE SYSTEM COMPONENTS LISTED IN THE TABLES MUST ONLY BE USED IN COMPLIANCE WITH THE GA-D366 INSTRUCTIONS FOR USE. IN GENERAL, THE USER IS ADVISED IN THE CORRESPONDING INSTRUCTIONS FOR USE GA-D366/EN/2018-03 V5.0 PK 18-9297 UNDER SECTION 8 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE USE. DO NOT USE PRODUCTS THAT ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. POSSIBLE DAMAGE OR DEVIATIONS CAN BE EASILY DETECTED BY HOSPITAL PERSONNEL.". PROBABLE ROOT CAUSE IS THOUGHT TO BE USER HANDLING ISSUE. THE ELECTRODES WERE SCRAPPED.

  Patient problems: Insufficient Information

  MAUDE report 10728745 ↗
• MalfunctionOct 23, 2020Break; Break

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. THE DEVICE WAS RECEIVED VISUALLY EVALUATED. THE REPORTED CONDITION (LOOPS BURNED) WAS CONFIRMED. ACCORDING TO THE MANUFACTURER: "AFTER CONSULTATION WITH THE USER IT WAS DETERMINED THAT THE ELECTRODES WERE USED WITH A MEDTRONIC GENERATOR. THIS CAUSED THE USER TO USE 3-4 ELECTRODES PER TURP. THE GENERATOR WAS REPLACED AND IT WAS DETERMINED THAT THE MEDTRONIC GENERATOR WAS CAUSING THE LOOPS TO BURN OUT COMPLETELY. ACCORDING TO THE SUPPLEMENT BB-D366, SYSTEM OVERVIEW "SHARK" RESECTOSCOPES, THE SYSTEM COMPONENTS LISTED IN THE TABLES MUST ONLY BE USED IN COMPLIANCE WITH THE GA-D366 INSTRUCTIONS FOR USE. IN GENERAL, THE USER IS ADVISED IN THE CORRESPONDING INSTRUCTIONS FOR USE GA-D366/EN/2018-03 V5.0 PK 18-9297 UNDER SECTION 8 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE CARRIED OUT BEFORE USE. DO NOT USE PRODUCTS THAT ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. POSSIBLE DAMAGE OR DEVIATIONS CAN BE EASILY DETECTED BY HOSPITAL PERSONNEL." PROBABLE ROOT CAUSE IS THOUGHT TO BE USER HANDLING ISSUE THE ELECTRODES WERE SCRAPPED.

  Patient problems: Insufficient Information

  MAUDE report 10727962 ↗